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Completed

NCT Number: NCT01509105

Prevenar13 Post Market Surveillance

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

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Key information

Conditions

Healthy

Age range

6 week–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Choi's Pediatric Clinic, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

About this study

non-randomization, non-probability sampling

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion criteria

  • Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Treatment and study plan

13-valent pneumococcal vaccine

Biological

0.5mL IM (Intramuscular administration) as per recommended schedule

Other names: Prevenar 13

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1

    Time frame: Within 7 days after Vaccination 1

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  2. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2

    Time frame: Within 7 days after Vaccination 2

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  3. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3

    Time frame: Within 7 days after Vaccination 3

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  4. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4

    Time frame: Within 28 days after Vaccination 4

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  5. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1

    Time frame: Within 7 days after Vaccination 1

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  6. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2

    Time frame: Within 7 days after Vaccination 2

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  7. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3

    Time frame: Within 7 days after Vaccination 3

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  8. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4

    Time frame: Within 28 days after Vaccination 4

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary outcomes

  1. Duration of Adverse Events (AEs)

    Time frame: Baseline up to 28 days after last dose of study vaccination (13 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.

  2. Number of Participants With Adverse Events (AEs) by Severity

    Time frame: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).

  3. Number of Participants With Outcome in Response to Adverse Events (AEs)

    Time frame: Baseline up to 28 days after last dose of study vaccination (13 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.

  4. Number of Participants Discontinued Due to Adverse Events

    Time frame: Baseline up to 28 days after last dose of study vaccination (13 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance To Observe Safety Of Prevenar 13

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2012
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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